SULFASALAZINE (SALAZOPYRINE) print home print home
Sulfasalazine has been marketed internationally since 1944 under the brand name Salazopyrine and as the generic Sulfasalazine. It is available by prescription as 500 mg tablets. A 500 mg suppository and a 100 mg/ml suspension are also available.

WHAT DOES SULFASALAZINE DO?

Sulfasalazine is originally an antibiotic. It also has anti-inflammatory properties in joint inflammation, such as rheumatoid arthritis and ankylosing spondylitis, and in inflammatory bowel diseases such as Crohn's disease and ulcerative colitis. In dermatology, sulfasalazine is primarily used for pyoderma gangrenosum. In addition, there are several skin conditions for which sulfasalazine is sometimes prescribed but not the first choice, such as Behçet's syndrome, linear IgA dermatosis, mucosal pemphigoid, discoid lupus erythematosus, herpes gestationis, erythema elevatum diutinum, dermatitis herpetiformis, chronic idiopathic urticaria and delayed pressure urticaria, subcorneal pustular dermatosis (Sneddon-Wilkinson), and vasculitis.

In the intestine, sulfasalazine is split into two substances: mesalazine and sulfapyridine. Mesalazine has an anti-inflammatory effect on the intestinal wall. Sulfapyridine is primarily anti-inflammatory for joint pain.

FOR WHAT CONDITIONS IS SULFASALAZINE USED?

Ulcerative colitis
Ulcerative colitis causes symptoms such as frequent and severe diarrhea, often with blood and mucus. Other symptoms include abdominal pain, fever, dehydration, anemia, and weight loss. In ulcerative colitis, the lining of the last part of the intestine, the large intestine, is chronically inflamed, without an infection. Usually, only the last part of the intestine is affected, but over the years, the disease can spread to the rest of the large intestine. In ulcerative proctitis, the inflammation is in the last part of the intestine, the rectum.

Attacks of ulcerative colitis can be effectively treated with 5-ASA medications, such as sulfasalazine. This medication is also used to prevent new attacks. The doctor prescribes the brand and dosage form depending on the precise location of the inflammation in the intestines. Each product releases the active ingredient in a different part of the intestine. For ulcerative proctitis, the doctor usually prescribes suppositories. For inflammation in even higher parts of the intestine, tablets or a liquid are necessary.

Dosage for large bowel disorders: initial dose: 4-12 tablets per day (=24 hours), children 2-8 years, 50 mg per kg body weight. Maintenance dose: 2-4 tablets per day for 3-6 months.

Crohn's disease
Crohn's disease is a chronic condition in which parts of the intestine are chronically inflamed, without an infection. The inflammation causes abdominal pain, fever, diarrhea, fatigue, and weight loss. Crohn's disease is a chronic condition in which periods of few symptoms alternate with periods of disease flare-ups. The inflammation penetrates deep into the muscle layers of the intestines. Usually, the last part of the small intestine and the first part of the large intestine are affected. The chronic inflammation causes thickenings in the intestine, making it difficult for stool to pass. Connecting tubes (fistulas) also develop from the intestine to other organs, such as the bladder, the vagina, and between different parts of the intestine.

It is important to prevent inflammation as much as possible and, if it does occur, to slow it down so that abdominal pain decreases and no lumps or fistulas develop. Crohn's disease can be treated with 5-ASA medications, such as sulfasalazine. This medication inhibits inflammation and sometimes prevents new attacks. The effectiveness of tablets or oral solution may be reduced in cases of diarrhea, as the active ingredient is released from the intestines later than intended.

Rheumatoid arthritis
Rheumatoid arthritis (RA) is a chronic inflammation of the joints, often of the hands and feet. This inflammation is accompanied by swelling, pain, and reduced joint mobility. The cause of rheumatic diseases cannot be treated with medication. However, there are medications that can alleviate these conditions; these are called anti-rheumatic drugs. After some time, these can reduce symptoms such as pain, stiffness, and swelling of the joints.
Sulfasalazine is one such medication. It can take two to three months before you notice its effects. If you are already taking painkillers, you can continue taking them. If sulfasalazine is beneficial, you can continue taking it for years. Unfortunately, it does not have a beneficial effect in everyone. If it doesn't work for you or if you experience too many side effects, your rheumatologist may decide to discontinue sulfasalazine use.

It is common to gradually increase the dosage to the desired amount per day (usually two tablets twice a day). Use this schedule:
morning: evening:
day 1-4 1 tablet 1 tablet
day 5-9 1 tablet 2 tablets
then 2 tablets 2 tablets
Other joint complaints
This medication is used not only for rheumatism but also for ankylosing spondylitis (Bechterew's disease). The effect is never immediate, but usually only after two to four months.

Pyoderma gangrenosum
Pyoderma gangrenosum is a rare inflammatory skin disease in which ulcers can develop spontaneously or after injury and slowly enlarge. It can occur in healthy people, but in about half of the cases, there is an underlying condition, such as Crohn's disease, ulcerative colitis, or rheumatism. Pyoderma gangrenosum can cause significant damage, so it is usually treated initially with a fast-acting medication such as prednisone. However, it is then worth trying sulfasalazine. Sulfasalazine also works very well in most patients and has far fewer unpleasant side effects than prednisone. Because sulfasalazine doesn't work immediately, but only after several weeks, it's wise to start by using both prednisone and sulfasalazine simultaneously, and then gradually reduce the prednisone.

The usual dosage for pyoderma gangrenosum is 1 gram three times a day. Sometimes a higher dose, up to 1.5 grams three times a day, is necessary. For pyoderma gangrenosum as well, it's wise to gradually increase the dosage to get used to the medication.
morning: afternoon: evening:
day 1, 2, 3 1 tablet 1 tablet
day 4, 5, 6 1 tablet 1 tablet 1 tablet
day 7, 8, 9 1 tablet 1 tablet 2 tablets
day 10,11,12 1 tablet 2 tablets 2 tablets
then 2 tablets 2 tablets 2 tablets

It's best to take the tablets with food, water, or milk. When using enteric-coated tablets, it's important that you swallow them whole, not break or chew them. Enteric

-coated tablets: Swallow the tablet whole with half a glass of water without chewing. This keeps the protective layer intact. This protective layer should only dissolve in the intestines, so that the active ingredient is released there and not already in the stomach.
Regular tablets: You may break or crush regular tablets. Take with some water.
Drink: Shake the drink well before each use.
Suppositories: Go to the toilet beforehand. Insert the suppository into the anus. It doesn't matter whether you insert the suppository with the tip forward or with the blunt end forward. Moistening the suppository with a little water makes it easier to insert. If you lose the suppository within ten minutes because you need to go to the toilet, you can insert a new one.

Forgotten to take tablets
If you forget to take a dose, take it as soon as possible. If the time until your next dose is shorter than the time until the missed dose, you do not need to do anything. It is better to skip the missed dose. Do not take a double dose.

Overdose
If you take too much, the following symptoms may occur:
- nausea, vomiting, diarrhea, headache, dizziness.
If you suspect an overdose, contact a doctor immediately.

SIDE EFFECTS

In addition to the desired effect, this medication may cause side effects. The extent to which these occur depends largely on the dosage. The most important side effects are gastrointestinal complaints, headache, dizziness, mood swings, hypersensitivity, kidney or pancreatic damage, and blood count abnormalities.
People with porphyria or a G6PD enzyme deficiency may experience side effects from this medication and should therefore not use it.

Common
- Gastrointestinal complaints, such as abdominal pain, loss of appetite, nausea, and vomiting.
With tablets or oral solution, you can often prevent this by taking them during or just after a meal.
With suppositories: a tingling sensation in the anus.
With tablets and oral solution: this medication may give urine and stool a yellow or orange color. This is harmless and will disappear once you stop taking the tablets.

Sometimes
- Headache and dizziness
- Tinnitus
- Increased temperature, red skin
- Fatigue.

Rarely
- Diarrhea (this can usually be prevented by gradually increasing the dosage).
- Mood changes, such as depressed mood, irritability, and nervousness.
- Temporary infertility in men, due to a low sperm count. This usually resolves within two to three months of stopping treatment.
- Hypersensitivity, manifested by a rash, itching, shortness of breath, joint pain, a sore tongue, or fever.
- Light sensitivity, to UV light (for example, from the sun or a tanning bed).
- Inflammation of the mucous membranes of the mouth, such as sore spots.
- Yellowing of the skin, blue discoloration of the skin.
- Skin rash.
- Urticaria (hives) or angioedema.
- Very rarely, a form of severe hypersensitivity may occur, manifested by fever, shortness of breath, blisters on the skin, or a swollen face and throat. In that case, contact a doctor immediately. Have you ever had an allergic reaction to a medicine from the salicylates group, such as acetylsalicylic acid, or to a sulfonamide (sulfa), such as certain antibiotics? If you are taking this medication, do not start immediately but consult your doctor or pharmacist first. You may need to use a different medication due to hypersensitivity.

Very rarely
: Kidney damage, which may be permanent. The risk of this side effect is higher after prolonged use. If you use this medication for an extended period, your doctor will therefore monitor your kidney function regularly.
- Blood in the urine, cloudy urine.
- Inflammation of the pancreas or liver. You won't notice this, but it can be detected in a blood test.
- Abnormalities in the blood count. Anemia, unexpected bleeding and/or bruising. Increased susceptibility to infection (leukopenia). Your doctor will therefore check your blood regularly.
- Sore throat with fever, frequent nosebleeds, and easy bruising (these are all signs of a blood production disorder). If you suddenly develop a fever, sore throat, mouth blisters, or nosebleeds, contact your doctor immediately.
- Porphyria attack. If you have porphyria, a metabolic disorder that causes attacks of abdominal pain, vomiting, fever, and palpitations: this medication can trigger an attack.
- If you are of African or Mediterranean descent, you may (but do not necessarily) have a congenital enzyme deficiency (G6PD deficiency), which could cause this medication to cause a serious blood disorder. As soon as you experience symptoms such as fatigue or dizziness, discontinue use and contact your doctor.
- Stevens-Johnson syndrome (a condition characterized by inflammation of the skin and mucous membranes), Lyell's syndrome (a skin rash accompanied by peeling and necrosis of the skin, accompanied by blistering).
- Nervous disorder. You can recognize this by loss of strength, rapid fatigue, irritability, or failure.

Consult your doctor if any of the above side effects bother you too much, or if you experience other side effects that you are concerned about.
Contact your doctor immediately if you have:
- skin rash
- inflammation of the oral mucosa
- severe sore throat with fever
- repeated nosebleeds
- easy bruising.

INTERACTIONS (interaction with other medicines)

Always inform your doctor and pharmacist if you are taking any other medicines in addition to this medicine. Some medicines can strengthen or weaken the effect of each other or should not be used at the same time for other reasons. Medicines that are known to influence the effect of sulfasalazine or whose effect is influenced by sulfasalazine include:
- antibiotics (medicines against infections); antibiotics that affect intestinal flora inhibit the conversion of sulfasalazine
- salicylates (painkillers); the absorption of sulfasalazine can be affected
- iron preparations; the absorption of sulfasalazine can be affected
- colestyramine (medicine used to treat high cholesterol); the absorption of sulfasalazine can be affected
- folic acid (vitamin B11); when used together, the absorption of folic acid can be reduced
- digoxin (medicine used to treat heart disease); when used together, the absorption of digoxin can be reduced
- oral agents that prevent blood clotting The effectiveness of these medications may be increased
- diabetes tablets; the effectiveness of these tablets may be increased.

If you are taking these or other medications, please take this into account and ask your doctor or pharmacist for advice.

DRIVING:

This medicine may cause dizziness as a side effect. Therefore, be careful when performing activities that require alertness, such as driving, operating machinery, and working at heights. Keep a close eye on children taking this medicine when they are playing outdoors.

ALCOHOL USE:

Be careful with your alcohol consumption. Combining sulfasalazine increases the risk of stomach upset or liver damage. Therefore, do not consume more than one alcoholic drink per day.

PREGNANCY AND BREASTFEEDING

Pregnancy:
In low doses (up to 2 grams per day), sulfasalazine can be used safely during pregnancy, as far as is known. It has been used by pregnant women for years without adverse effects on the baby. However, you must also take folic acid to prevent side effects in the baby. Consult your doctor before using higher doses.

Breastfeeding:
If you wish to breastfeed, consult your doctor. This medication passes into breast milk. At a low dose of up to 2 grams per day, this usually does not cause any problems. If you do breastfeed, the doctor will monitor the baby more closely for side effects, such as diarrhea.

Fertility:
Sulfasalazine does not affect fertility in women. It can cause temporary reduced fertility in men. This usually resolves a few months after the medication is discontinued. Men who wish to have children can therefore continue using sulfasalazine.

Children under 2 years:
Insufficient data are available on the use of sulfasalazine in children under 2 years of age. Therefore, sulfasalazine should not be used in children under 2 years of age.

Monitoring:
During treatment, you must be closely monitored by your doctor, especially in the first 3 months. To detect any disturbances in liver function and blood production at an early stage, your doctor will have your blood tested regularly. This is usually done every two weeks initially. After this, the check-ups will be less frequent.
Consult your doctor if your condition worsens or if you experience bothersome side effects. Treatment must be stopped immediately if serious symptoms of poisoning occur or if you are hypersensitive to the tablets. If you are hypersensitive to medicines that are chemically similar to sulfasalazine (certain antibiotics (sulfonamides), some diuretics, and diabetes tablets), you may also be hypersensitive to sulfasalazine tablets.

Can I stop taking this medication suddenly?
If you have been taking this medication for a long time, you can usually stop immediately. Symptoms may return.

Storage:
Store the tablets in their original packaging in a dry place (bathrooms and kitchens are not suitable) at temperatures not exceeding 25°C. Always keep medicines out of reach of children.
Source: www.skin-diseases.eu 2023
14-09-2025 ( JRM ) www.skin-diseases.eu pocketbook

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